IACFS/ME on a Roll; Stanford to the Fore! Treatment Primer Gains Recognition and More

The IACFS/ME Newsletter was chock full of good news this time... For starters, Stanford, of all places is co-sponsoring the next IACFS/ME Conference!Stanford University to Co-sponsor IACFS/ME Conference in March, 2014

[caption id="attachment_13299" align="alignright" width="300"] In a surprise, Stanford, the 4th ranked medical research university in the U.S., will co-sponsor the next IACFS/ME Conference in 2012[/caption]

Patient groups groups have always co- hosted IACFS/ME conferences in the past but that's changed - and in a big way. One might have thought the first University to co-sponsor an IACFS/ME conference would be a small one but no, in a stunning turn of events, somehow the IACFS/ME, Dr. Montoya and Dr. Lily Chu got Stanford, ranked #4 in medical research in the country, to co-sponsor the next one in March, 2014. That should raise some eye-brows in the academic field.

We don't know where in the Bay Area the Conference will take place but with two of the top medicals schools in the country, Stanford and the University of San Francisco nearby, the opportunity for collaboration and outreach is large. Conferences and workshops are where the seeds for future collaboration are planted and the San Franciso Bay area provides very fertile soil for that. Congratulations to the IACFS/ME, Dr. Montoya and Dr. Chu for creating this breakthrough in Conference sponsorship.

The fact that it has happened suggests that Dr. Montoya is making progress within what must be a very rigorous and at times probably difficult research setting for ME/CFS.Open Medicine Institute

It'll be intriguing to see how the nearby Open Medicine Institute will figure in the conference and we got a short update on their activities in an attachment to the newsletter. The Institute's founder, Dr. Andreas Kogelnik, recently convened a collaborative group of international researchers (US, Canada, Norway, Sweden, Germany, UK, Italy, and Australia) to create and act on a list of diagnostic and treatment studies over the next 12-24 months. That list will be published and fundraising efforts begun to support them in Sept of this year.

The OMI has not gotten much press but Dr. Kogelnik's vision is a very large one and they're clearly interested in major initiatives. Their ability to score a major grant from the CDC to study how prominent ME/CFS physicians diagnose this disorder suggests they have the rigor to participate successfully at that level. Phoenix Rising will be meeting with Dr. Kogelnik and Linda Tannenbaum in the near future and we'll provide a full report.Treatment Primer Gets on Federal Guidelines Site

The newsletter of the organization of chronic fatigue syndrome professionals, the IACFS/ME, is out and its got some good news. The IACFS/ME's Treatment Primer has been racking up some positive reviews. First, the federal committee on CFS, CFSAC, recommended that the Primer be widely disseminated to physicians and health care provider. Now the National Guideline Clearinghouse, a governmental agency tasked with providing information and guidelines on effective and safe healthcare, will put the Primer on their site in the fall. It will be the first guideline for ME/CFS treatment on the site. (The CDC CFS Toolkit is not on the site).

The Primer is undergoing a round of revisions as the authors receive comments on the first edition.

The first edition of the new Fatigue: Biomedicine, Health and Behavior Journal will be out early next year. The creation of a bona-fide ME/CFS journal accessible on major medical indexes has been a long time coming. The inability of the former Journal of Chronic Fatigue Syndrome to show up on those indexes meant that its impact was confined to the small ME/CFS research community.

Some tradeoffs were made. In order for the journal to be economically viable for the publisher it had to appeal to a wider audience than ME/CFS researchers - hence the general focus on fatigue. That focus may upset some patients but the broad focus on fatigue should put ME/CFS studies side by side with other fatiguing illnesses such as cancer, liver disease, multiple sclerosis providing valuable exposure for ME/CFS and providing new insights for ME/CFS researchers and vice versa. Find out more about the new Journal here.Invest in ME Conference Overview

Finally Dr. Roz Vallings of New Zealand provided another illuminating conference review with her review of the latest Invest In ME conference. Some highlights were:

Dr. Staines - keynote speech suggested ME/CFS is a novel auto-immune disorder involving vasoactive neuropeptides. (A recent study suggested he may be on the right track...more work is underway.)

Dr. Sonya-Marsall Gradisnuk of PHANU - highlighted a bevy of potential natural killer cell biomarkers for ME/CFS....Expect much more on NK cells from them in the future.

Dr Fitzgerald - described altered brain activity in ME/CFS and FM that leads to increased pain.

Dr. Delagado - on the importance of vaso-active neuropeptides in treating inflammation and auto-immunity and a drug (avipatadil) that may be helpful

Dr. Baraniuk - was able to subset 4 groups of patients using his spinal proteome results. He believes brainstem problems play a major role and that the bodies 'alarm clock' is damaged. His finding that the increased activity of the pain processing nerves around the joints and muscles in FM probably due to sympathetic nervous system problems fits the 'alarm' scenario; the SNS controls the 'fight/flight' response.

Professors Mella and Fluge - found a 67% positive rate in their Rituximab trials but emphasized they do not believe Rituximab treatment should take place outside of clinical trials. Several studies are ongoing. After three years of searching they have not been able to find a specific autoantibody and believe that something else may be producing the inflammation in ME/CFS.

Dr. Peterson - provided an overview of the many new project he and others are involved in.

Dr. Kogelnik - described a large number of projects getting underway at the OMI including viral, antibody and cytokine research studies, treatment studies involving Rituximab, antivirals and antibiotics and others.

I have had a bad month and reading this gives me a lot of hope. I just wish the conference was earlier. 2014 seems such a long way away. Oh well: it gives me time to save money for the trip since I plan on attending. I'm sure there will be a lot of good news by then.

I have had a bad month and reading this gives me a lot of hope. I just wish the conference was earlier. 2014 seems such a long way away. Oh well: it gives me time to save money for the trip since I plan on attending. I'm sure there will be a lot of good news by then.

Great news.. but so frustrating on so many levels. They obviously now acknowledge that all of us are "really" physically sick, but now we have to try to sift through their findings and theories, while meanwhile more years of our lives are lost, bein on the couch. sigh

I have had a bad month and reading this gives me a lot of hope. I just wish the conference was earlier. 2014 seems such a long way away. Oh well: it gives me time to save money for the trip since I plan on attending. I'm sure there will be a lot of good news by then.

Gamboa

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Sorry to hear that Gamboa...yes, it is a ways away but I think it will be a terrific conference. By then we'll have great pathogen data, Dr. Montoya will have published his results , I imagine the Open Medicine Institute will be buzzing, we'll know alot more about Rituximab, PHANU will have extended their excited NK findings (can you say biomarker?)...if things work we could be something of a hot item by then...who knows?

Their ability to score a major grant from the CDC to study how prominent ME/CFS physicians diagnose this disorder suggests they have the rigor to participate successfully at that level.

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It's news when the CDC sets the standard for rigour!

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I thought that would tweak a few people What I was told from Suzanne Vernon, though, was that the forms required for get that grant were extensive and difficult and she felt the fact that the OMI was able to handle that and get the grant was a very good sign for them..

Dr. Belay certainly “tweaked” a few people at the June CFSAC meeting when he explained that the CDC isn't studying “how prominent physicians diagnose this disorder.” That's precisely what they're not asking. If you missed that exchange, Cort, both the video and minutes are available now. Here's how some members challenged the CDC's research design:

Dr. Belay: When I say data, a good example I could use is the data that we’re collecting in the seven clinics. The data that’s being collected in the seven clinics does not specify any case definition. It’s just the best judgment of physicians who have treated CFS patients for years and years using their best judgment. What are the cases that they would classify as having CFS in collecting as many parameters as possible that would al low us then to apply to those case definitions and see how those case definitions would compare....

Mr. Krafchick: The problem is that you still have to identify the patients ahead of time.

Dr. Fletcher: What definition did you use?

Dr. Belay: We are using the best judgment.

Mr. Krafchick: So there are no criteria. That’s not going to work real well....

Ms. Holderman: At the five centers, did you say to the investigators, “Collect the data and the data set is up to you to use whatever criteria is out there? Are they naming the criteria?

Dr. Belay: We basically left it to them to make that decision using their best judgment. We don’t want to box them in to a case definition....

Ms. Holderman: So in other words, do they know what criteria they’re using or are they blending them?

Dr. Belay: We have to trust physicians at one point. These are physicians who have a lot of experience. They have been treating ME/CFS for years and years and years. For example, we have Dr. Klimas and Dr. Klimas sees from her judgment and her practice, using whatever criteria she uses, that a particular patient is a CFS patient. We’re going to use him or her in the study.

Dr. Fletcher: I can tell you for sure what Nancy Klimas uses on all patients put into a research study. Now she uses the Canadian. Before that she used Fukuda. And I can also say that Reeves did a lot of damage when he at the CDC made that revision of the Fukuda that opened up the case definition to a whole lot of people with depression. We have to be really careful about this kind of thing.

Dr. Lee: It may be that it is not the research definition that Dr. Klimas is using but who she is treating for CFS in her practice and who she says, to the patient, you have CFS.

Dr. Fletcher: That’s what she uses to say that to them. She wouldn’t want to say to a patient that you have CFS if they didn’t meet some definition....

Ms. Holderman: So you’re not asking the investigators of those five places to decide what kind of criteria they’re using. You’re saying pick your patients, collect their symptoms, and never reveal what criteria you based it on? ... They do know what criteria they’re using, right?

Dr. Belay: Of course.

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Again, the prominent clinicians are pointedly not being asked how they “diagnose this disorder.” I don't understand what's to be gained by suggesting that the CDC study itself is anything but horribly flawed.

Montoya is firmly rooted in the HHV-6 = CFS camp. Treatment = long-term anti-virals. I thought we already went down this road? ... (he talks about this on youtube, if you haven't heard him)

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We went down this road before, and it was the right one. Montoya's double-blind Valcyte study back in 2007 was falsely portrayed as a failure because the treatment group didn't improve over the placebo group at 6 months in any areas other than cognitive function. But these were only preliminary results- the full paper is still in peer review.

When they gathered data over a longer period of time, they found that the treatment group continued to improve while the placebo group languished. By the one year mark all symptom domains showed a statistically and clinically significant improvement.

The same time-lag pitfall has applied to all the effective treatments for CFS. Ampligen's effects are barely significant at 6 months but there is a big difference after 18 months. The authors of the Norwegian Rituxan study set a primary endpoint as CFS symptoms 3 months post-treatment. Rituxan failed to benefit most people in the study by three months but most people were better 6-8 months after a single dose of the b-cell depleting drug..

Dr. Belay certainly “tweaked” a few people at the June CFSAC meeting when he explained that the CDC isn't studying “how prominent physicians diagnose this disorder.” That's precisely what they're not asking. If you missed that exchange, Cort, both the video and minutes are available now. Here's how some members challenged the CDC's research design:

Dr. Belay: When I say data, a good example I could use is the data that we’re collecting in the seven clinics. The data that’s being collected in the seven clinics does not specify any case definition. It’s just the best judgment of physicians who have treated CFS patients for years and years using their best judgment. What are the cases that they would classify as having CFS in collecting as many parameters as possible that would al low us then to apply to those case definitions and see how those case definitions would compare....

Mr. Krafchick: The problem is that you still have to identify the patients ahead of time.

Dr. Fletcher: What definition did you use?

Dr. Belay: We are using the best judgment.

Mr. Krafchick: So there are no criteria. That’s not going to work real well....

Ms. Holderman: At the five centers, did you say to the investigators, “Collect the data and the data set is up to you to use whatever criteria is out there? Are they naming the criteria?

Dr. Belay: We basically left it to them to make that decision using their best judgment. We don’t want to box them in to a case definition....

Ms. Holderman: So in other words, do they know what criteria they’re using or are they blending them?

Dr. Belay: We have to trust physicians at one point. These are physicians who have a lot of experience. They have been treating ME/CFS for years and years and years. For example, we have Dr. Klimas and Dr. Klimas sees from her judgment and her practice, using whatever criteria she uses, that a particular patient is a CFS patient. We’re going to use him or her in the study.

Dr. Fletcher: I can tell you for sure what Nancy Klimas uses on all patients put into a research study. Now she uses the Canadian. Before that she used Fukuda. And I can also say that Reeves did a lot of damage when he at the CDC made that revision of the Fukuda that opened up the case definition to a whole lot of people with depression. We have to be really careful about this kind of thing.

Dr. Lee: It may be that it is not the research definition that Dr. Klimas is using but who she is treating for CFS in her practice and who she says, to the patient, you have CFS.

Dr. Fletcher: That’s what she uses to say that to them. She wouldn’t want to say to a patient that you have CFS if they didn’t meet some definition....

Ms. Holderman: So you’re not asking the investigators of those five places to decide what kind of criteria they’re using. You’re saying pick your patients, collect their symptoms, and never reveal what criteria you based it on? ... They do know what criteria they’re using, right?

Dr. Belay: Of course.

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Again, the prominent clinicians are pointedly not being asked how they “diagnose this disorder.” I don't understand what's to be gained by suggesting that the CDC study itself is anything but horribly flawed.

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I actually think they're doing this exactly right. My guess is that these physicians don't tick off the parameters of the Fukuda or the CCC criteria when they look at patients. They ask them questions and determine for themselves who has CFS and who does not. If the CDC asked them what specific definition they're using they'd probably be putting them in a box that just doesn't fit them; ie they'd have to translate their diagnostic protocols into a definition...Instead the CDC is simply letting them tell the CDC in their own words how they diagnose patients. After that the CDC will be able presumably how well each physicians approach fits the different definitions.

I actually think they're doing this exactly right. My guess is that these physicians don't tick off the parameters of the Fukuda or the CCC criteria when they look at patients. They ask them questions and determine for themselves who has CFS and who does not. If the CDC asked them what specific definition they're using they'd probably be putting them in a box that just doesn't fit them; ie they'd have to translate their diagnostic protocols into a definition...Instead the CDC is simply letting them tell the CDC in their own words how they diagnose patients. After that the CDC will be able presumably how well each physicians approach fits the different definitions.

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Read again, Cort. The CDC isn't letting the clinicians "tell [them] in their own words how they diagnose patients." They're simply asking them to select CFS patients, without explicit reference to any criteria. Dr. Belay explains, “For example, we have Dr. Klimas and Dr. Klimas sees from her judgment and her practice, using whatever criteria she uses, that a particular patient is a CFS patient. We’re going to use him or her in the study.”

You write, “My guess is that these physicians don't tick off the parameters of the Fukuda or the CCC criteria when they look at patients. They ask them questions and determine for themselves who has CFS and who does not.” Where on earth does that guess come from? Dr. Fletcher explains that Dr. Klimas “wouldn’t want to say to a patient that you have CFS if they didn’t meet some definition.”

Here's how Dr. Peterson advises clinicians making a diagnosis:

So the most widely accepted definition is the Canadian Consensus, established in 2003. This is used in most clinical trials now. It's used as entrance criteria into the upcoming Columbia studies with Ian Lipkin. It's used in a number of drug trials, etc. So I encourage if there are physicians who aren't using this definition, they should be. This has now been automated, so that there's a downloadable program, so you can simply tick through the questions and find out if the patient meets the CDC criteria or the Canadian Consensus Criteria or both.And that's very helpful for physicians because it was cumbersome to figure out whether or not they met the criteria. And that has an iPad application even, so it's really helpful (emphasis added).

I actually think they're doing this exactly right. My guess is that these physicians don't tick off the parameters of the Fukuda or the CCC criteria when they look at patients. They ask them questions and determine for themselves who has CFS and who does not. If the CDC asked them what specific definition they're using they'd probably be putting them in a box that just doesn't fit them; ie they'd have to translate their diagnostic protocols into a definition...Instead the CDC is simply letting them tell the CDC in their own words how they diagnose patients. After that the CDC will be able presumably how well each physicians approach fits the different definitions.

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Read again, Cort. The CDC isn't letting the clinicians "tell [them] in their own words how they diagnose patients." They're simply asking them to select CFS patients, without explicit reference to any criteria. Dr. Belay explains, “For example, we have Dr. Klimas and Dr. Klimas sees from her judgment and her practice, using whatever criteria she uses, that a particular patient is a CFS patient. We’re going to use him or her in the study.”

You write, “My guess is that these physicians don't tick off the parameters of the Fukuda or the CCC criteria when they look at patients. They ask them questions and determine for themselves who has CFS and who does not.” Where on earth does that guess come from? Dr. Fletcher explains that Dr. Klimas “wouldn’t want to say to a patient that you have CFS if they didn’t meet some definition.”

Here's how Dr. Peterson advises clinicians making a diagnosis:

So the most widely accepted definition is the Canadian Consensus, established in 2003. This is used in most clinical trials now. It's used as entrance criteria into the upcoming Columbia studies with Ian Lipkin. It's used in a number of drug trials, etc. So I encourage if there are physicians who aren't using this definition, they should be. This has now been automated, so that there's a downloadable program, so you can simply tick through the questions and find out if the patient meets the CDC criteria or the Canadian Consensus Criteria or both.And that's very helpful for physicians because it was cumbersome to figure out whether or not they met the criteria. And that has an iPad application even, so it's really helpful (emphasis added).

: 16:20-17:15.

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In reality, Dr. Peterson doesn't exactly follow the CCC or CDC definitions. He has been using specific lab tests and functional tests to help identify CFS cases for well over a decade. While he goes through an exhaustive effort to exclude non-CFS causes of patients' symptoms (more thorough than the ones required by the definitions!) he does not subscribe to the notion that CFS is purely a diagnosis of exclusion. He rejects this idea. He would say that clinically useful biomarkers have existed for many years.

I actually think they're doing this exactly right. My guess is that these physicians don't tick off the parameters of the Fukuda or the CCC criteria when they look at patients. They ask them questions and determine for themselves who has CFS and who does not. If the CDC asked them what specific definition they're using they'd probably be putting them in a box that just doesn't fit them; ie they'd have to translate their diagnostic protocols into a definition...Instead the CDC is simply letting them tell the CDC in their own words how they diagnose patients. After that the CDC will be able presumably how well each physicians approach fits the different definitions.

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Read again, Cort. The CDC isn't letting the clinicians "tell [them] in their own words how they diagnose patients." They're simply asking them to select CFS patients, without explicit reference to any criteria. Dr. Belay explains, “For example, we have Dr. Klimas and Dr. Klimas sees from her judgment and her practice, using whatever criteria she uses, that a particular patient is a CFS patient. We’re going to use him or her in the study.”

You write, “My guess is that these physicians don't tick off the parameters of the Fukuda or the CCC criteria when they look at patients. They ask them questions and determine for themselves who has CFS and who does not.” Where on earth does that guess come from? Dr. Fletcher explains that Dr. Klimas “wouldn’t want to say to a patient that you have CFS if they didn’t meet some definition.”

Here's how Dr. Peterson advises clinicians making a diagnosis:

So the most widely accepted definition is the Canadian Consensus, established in 2003. This is used in most clinical trials now. It's used as entrance criteria into the upcoming Columbia studies with Ian Lipkin. It's used in a number of drug trials, etc. So I encourage if there are physicians who aren't using this definition, they should be. This has now been automated, so that there's a downloadable program, so you can simply tick through the questions and find out if the patient meets the CDC criteria or the Canadian Consensus Criteria or both.And that's very helpful for physicians because it was cumbersome to figure out whether or not they met the criteria. And that has an iPad application even, so it's really helpful (emphasis added).

: 16:20-17:15.

Click to expand...

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In reality, Dr. Peterson doesn't exactly follow the CCC or CDC definitions. He has been using specific lab tests and functional tests to help identify CFS cases for well over a decade. While he goes through an exhaustive effort to exclude non-CFS causes of patients' symptoms (more thorough than the ones required by the definitions!) he does not subscribe to the notion that CFS is purely a diagnosis of exclusion. He rejects this idea. He would say that clinically useful biomarkers have existed for many years.

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The ultimate goal here with this study (at least for us) is that the CDC gets that information and starts acting on it...Who knows - if the data supports Dr. Peterson's ideas (and I assume it does ) then if the CDC is rigorous enough they'll act on it....Certainly there is agreement on the NK cell functional data between Dr. Peterson, Dr. Klimas, the PHANU researchers and others...and general agreement on the VO2 max data...I assume that is what he is focused on...

The OMI is in the process of re-upping the grant and trying to extend it to include much more information....Hopefully they'll get it. I would note that Dr. Peterson is very high on this project - I hope it works out.

Who knows - if the data supports Dr. Peterson's ideas (and I assume it does ) then if the CDC is rigorous enough they'll act on it....Certainly there is agreement on the NK cell functional data between Dr. Peterson, Dr. Klimas, the PHANU researchers and others...and general agreement on the VO2 max data...I assume that is what he is focused on...

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At issue here is rigour of the CDC research design. There's no plan for Dr. Klimas (or the PHANU) to be involved, and Dr. Unger isn't willing to commit to the VO2 max test.

Dr. Unger writes, “We are planning to collect standardized data on all the domains of illness included in the Canadian Consensus Criteria of CFS/ME (sic), the 1994 CFS definition and the newly proposed International ME definition.” After “collecting as many parameters as possible,” the CDC plans to create its new definition by using the core symptoms of the 400 preselected CFS patients and applying unspecified instruments (subject to there being any good ones) to the resulting symptom domains in order to establish severity cut-offs.